Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 28, 42, 56, and every 28 days thereafter through Week 32 (9 doses). Tetanus toxoid and pneumococcal vaccinations are administered on the same day 4 weeks prior to the first dose of belimumab.

Other Name: BENLYSTA™

Experimental: Belimumab plus Late Vaccination

Belimumab plus Late Vaccination

Biological: Belimumab plus Late Vaccination

Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 0, 14, 28, and then every 28 days thereafter through Week 28 (9 doses). Tetanus toxoid and pneumococcal vaccinations are administered on the same day 24 weeks after the first dose of belimumab.

Other Name: BENLYSTA™

Detailed Description:

All patients in this study will receive belimumab plus standard therapy for SLE and vaccinations against pneumococcus and tetanus toxoid. Patients will be randomized to receive vaccinations either 4 weeks prior (early vaccination group) or 24 weeks after (late vaccination group) their first belimumab dose. Vaccine response will be assessed 4 weeks after vaccine administration.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Key Inclusion Criteria:

Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

Active SLE disease.

Autoantibody-positive.

Have levels of antibodies to tetanus toxoid and pneumococcal vaccine that are below protective levels.

Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.

Key Exclusion Criteria:

Pregnant or nursing.

Have received any prior treatment with belimumab.

Have received a live vaccine within the past 30 days.

Have received a tetanus or pneumococcal vaccination with the past 5 years.

Have a history of severe allergic reaction to a vaccine, contrast agents (such as those used for x-rays and CT scans), or biological medicines.

Have required management of an infection or have had infections that keep coming back within the past 60 days.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597492